ID

39815

Beskrivning

Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01935700

Länk

https://clinicaltrials.gov/show/NCT01935700

Nyckelord

Versioner (2)
  1. 2020-02-23 2020-02-23 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01935700

Engelsk

Eligibility Hepatocellular Carcinoma NCT01935700

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. . patient has at least one of the following criteria: (1) positive for hepatocellular carcinoma evidenced by cytology or pathology, (2) serum alpha-fetoprotein level > 400 ng/ml and has evidence of hepatocellular carcinoma provided by contrast-enhanced computed tomography or magnetic resonance imaging.
Beskrivning

Liver carcinoma Positive Cytology | Liver carcinoma Positive Pathology | Alpha one fetoprotein measurement | Liver carcinoma CT scan contrast | Liver carcinoma Magnetic Resonance Imaging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1305671
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0919386
UMLS CUI [3]
C0201539
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0742919
UMLS CUI [5,1]
C2239176
UMLS CUI [5,2]
C0024485
2. . contrast-enhanced computed tomography or magnetic resonance imaging has evidence of distant metastasis or large vessel invasion caused by hepatocellular carcinoma.
Beskrivning

CT scan contrast | Magnetic Resonance Imaging | Distant metastasis caused by Liver carcinoma | Large vessel Invasion caused by Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0742919
UMLS CUI [2]
C0024485
UMLS CUI [3,1]
C1269798
UMLS CUI [3,2]
C0015127
UMLS CUI [3,3]
C2239176
UMLS CUI [4,1]
C0225990
UMLS CUI [4,2]
C1269955
UMLS CUI [4,3]
C0015127
UMLS CUI [4,4]
C2239176
3. . patient has child a hepatic reserved function
Beskrivning

Liver function Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. . there are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
Beskrivning

Hemorrhage Life Threatening | Gastrointestinal Hemorrhage | Hemorrhage Organ Vital | Pulmonary hemorrhage | Brain hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0017181
UMLS CUI [3,1]
C0019080
UMLS CUI [3,2]
C0178784
UMLS CUI [3,3]
C0442732
UMLS CUI [4]
C0151701
UMLS CUI [5]
C0553692
2. . there are life-threatening bacterial, fungal or viral infection (not included hepatitis b and c virus).
Beskrivning

Bacterial Infection Life Threatening | Mycoses Life Threatening | Virus Disease Life Threatening | Exception Hepatitis B | Exception Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0026946
UMLS CUI [2,2]
C2826244
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C2826244
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0019163
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0019196
3. . patient has serum creatinine level > 1.5 mg/dl.
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
4. . patient must receive long-term medication of statin or fibrates drugs and these medications can not be changed.
Beskrivning

Statins Long-term | Fibrates Long-term | Statins Change Unsuccessful | Fibrates Change Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0443252
UMLS CUI [2,1]
C1449704
UMLS CUI [2,2]
C0443252
UMLS CUI [3,1]
C0360714
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C1272705
UMLS CUI [4,1]
C1449704
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C1272705
5. . patient has white blood cell count < 1500/µl, platelet count < 30000/µl or hemoglobin < 9.0 gm/dl after medication.
Beskrivning

White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement | Status post Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0013227
6. . pregnant woman or plan to be a pregnant woman
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
7. . allergy to colchicine or has history of severe side effects caused by colchicine
Beskrivning

Colchicine allergy | Side effects caused by Colchicine

Datatyp

boolean

Alias
UMLS CUI [1]
C0571131
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0009262
8. . patient has received systemic chemotherapy within 2 months before enrollment or plans to receive systemic chemotherapy in the future.
Beskrivning

Systemic Chemotherapy | Systemic Chemotherapy Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C1883256
UMLS CUI [2,2]
C1301732
9. . patient is under or plans to receive nexavar or other clinical trial testing drug.
Beskrivning

Nexavar | Nexavar Planned | Investigational New Drugs Other | Investigational New Drugs Other Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C1677799
UMLS CUI [2,1]
C1677799
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0205394
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C0205394
UMLS CUI [4,3]
C1301732
10. . patient has severe malfunction of vital organs and can not participate in this study justified by the doctor in this research team.
Beskrivning

Malfunction Organ Vital | Study Subject Participation Status Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231174
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0442732
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332196
11. . patient is under or plans to receive chinese traditional medicine or herb drugs.
Beskrivning

Traditional Chinese Medicine Formulation | Traditional Chinese Medicine Formulation Planned | Chinese herbal medicine | Chinese herbal medicine Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C4331423
UMLS CUI [2,1]
C4331423
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C1273412
UMLS CUI [4,1]
C1273412
UMLS CUI [4,2]
C1301732
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Similar models

Eligibility Hepatocellular Carcinoma NCT01935700

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma Positive Cytology | Liver carcinoma Positive Pathology | Alpha one fetoprotein measurement | Liver carcinoma CT scan contrast | Liver carcinoma Magnetic Resonance Imaging
Item
1. . patient has at least one of the following criteria: (1) positive for hepatocellular carcinoma evidenced by cytology or pathology, (2) serum alpha-fetoprotein level > 400 ng/ml and has evidence of hepatocellular carcinoma provided by contrast-enhanced computed tomography or magnetic resonance imaging.
boolean
C2239176 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1305671 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0919386 (UMLS CUI [2,3])
C0201539 (UMLS CUI [3])
C2239176 (UMLS CUI [4,1])
C0742919 (UMLS CUI [4,2])
C2239176 (UMLS CUI [5,1])
C0024485 (UMLS CUI [5,2])
CT scan contrast | Magnetic Resonance Imaging | Distant metastasis caused by Liver carcinoma | Large vessel Invasion caused by Liver carcinoma
Item
2. . contrast-enhanced computed tomography or magnetic resonance imaging has evidence of distant metastasis or large vessel invasion caused by hepatocellular carcinoma.
boolean
C0742919 (UMLS CUI [1])
C0024485 (UMLS CUI [2])
C1269798 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C2239176 (UMLS CUI [3,3])
C0225990 (UMLS CUI [4,1])
C1269955 (UMLS CUI [4,2])
C0015127 (UMLS CUI [4,3])
C2239176 (UMLS CUI [4,4])
Liver function Child-Pugh Classification
Item
3. . patient has child a hepatic reserved function
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hemorrhage Life Threatening | Gastrointestinal Hemorrhage | Hemorrhage Organ Vital | Pulmonary hemorrhage | Brain hemorrhage
Item
1. . there are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
boolean
C0019080 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2])
C0019080 (UMLS CUI [3,1])
C0178784 (UMLS CUI [3,2])
C0442732 (UMLS CUI [3,3])
C0151701 (UMLS CUI [4])
C0553692 (UMLS CUI [5])
Bacterial Infection Life Threatening | Mycoses Life Threatening | Virus Disease Life Threatening | Exception Hepatitis B | Exception Hepatitis C
Item
2. . there are life-threatening bacterial, fungal or viral infection (not included hepatitis b and c virus).
boolean
C0004623 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0026946 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0019163 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0019196 (UMLS CUI [5,2])
Creatinine measurement, serum
Item
3. . patient has serum creatinine level > 1.5 mg/dl.
boolean
C0201976 (UMLS CUI [1])
Statins Long-term | Fibrates Long-term | Statins Change Unsuccessful | Fibrates Change Unsuccessful
Item
4. . patient must receive long-term medication of statin or fibrates drugs and these medications can not be changed.
boolean
C0360714 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C1449704 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
C0360714 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
C1449704 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C1272705 (UMLS CUI [4,3])
White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement | Status post Pharmaceutical Preparations
Item
5. . patient has white blood cell count < 1500/µl, platelet count < 30000/µl or hemoglobin < 9.0 gm/dl after medication.
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
Pregnancy | Pregnancy, Planned
Item
6. . pregnant woman or plan to be a pregnant woman
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Colchicine allergy | Side effects caused by Colchicine
Item
7. . allergy to colchicine or has history of severe side effects caused by colchicine
boolean
C0571131 (UMLS CUI [1])
C0879626 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0009262 (UMLS CUI [2,3])
Systemic Chemotherapy | Systemic Chemotherapy Planned
Item
8. . patient has received systemic chemotherapy within 2 months before enrollment or plans to receive systemic chemotherapy in the future.
boolean
C1883256 (UMLS CUI [1])
C1883256 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Nexavar | Nexavar Planned | Investigational New Drugs Other | Investigational New Drugs Other Planned
Item
9. . patient is under or plans to receive nexavar or other clinical trial testing drug.
boolean
C1677799 (UMLS CUI [1])
C1677799 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Malfunction Organ Vital | Study Subject Participation Status Excluded
Item
10. . patient has severe malfunction of vital organs and can not participate in this study justified by the doctor in this research team.
boolean
C0231174 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0442732 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Traditional Chinese Medicine Formulation | Traditional Chinese Medicine Formulation Planned | Chinese herbal medicine | Chinese herbal medicine Planned
Item
11. . patient is under or plans to receive chinese traditional medicine or herb drugs.
boolean
C4331423 (UMLS CUI [1])
C4331423 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1273412 (UMLS CUI [3])
C1273412 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
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